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    The EU Clinical Trials Register currently displays   34898   clinical trials with a EudraCT protocol, of which   5685   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-000050-23
    Sponsor's Protocol Code Number:28130
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-07-26
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzech Republic - SUKL
    A.2EudraCT number2004-000050-23
    A.3Full title of the trial
    Prospective, double-blind, randomized, placebo-controlled dose finding study of the efficacy and safety of 2 target doses of Org 34517 used as adjunctive therapy in subjects with psychotic major depression (major depressive episode, severe, with psychotic features)
    A.4.1Sponsor's protocol code number28130
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNV Organon
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOrg 34517
    D.3.2Product code Org 34517
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 189035-07-2
    D.3.9.2Current sponsor codeOrg 34517
    D.3.9.3Other descriptive name(11ß,17ß)-11-(1,3-benzodioxol-5-yl)-17- hydroxy-17-(1-propynyl)estra-4, 9-dien-3-one
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typea medicinal product with an active substance of chemical origin
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psychotic major depression (major depressive episode, severe, with psychotic features)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level LLT
    E.1.2Classification code 10037250
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of adjunctive treatment with 900 mg Org 34517, as compared to placebo, in alleviating psychotic symptoms in patients with psychotic depression on "usual treatment", as measured by the PANSS positive symptoms scale.
    E.2.2Secondary objectives of the trial
    - Additional efficacy assessments
    - Effects on cognition
    - Onset of action, maintenance of effect
    - Safety/tolerability
    - Population PK
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    a) provide voluntary written informed consent for trial participation after the scope and nature of the investigation have been explained to them, and before starting any trial-related activities (before Screening);
    b) be able to speak, read, understand, respond to questions, and follow instructions in English or their native language, if the investigator is fluent in that language and any required documents, including informed consent, can be translated into that language;
    c) have a DSM-IV severe depressive episode with psychotic features, as diagnosed by the MINI-Plus for single or recurrent episodes (296.24 or 296.34);
    d) have a score on PANSS item “Delusions” AND/OR “Hallucinatory behavior” of at least 4 at Screening and Baseline;
    e) have a PANSS Positive Scale score of at least 16 at Screening and Baseline;
    f) have a total score of at least 18 on the HAMD 17 item scale at Screening and Baseline;
    g) be on a stable dose of usual “treatment”, which has to consist of an antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes;
    h) be 18 up to and including 75 years of age at Screening;
    i) must be willing to be hospitalized for at least 11 days from Screening onwards. Interval between Screening and Baseline is 2 - 3 days and 1 day is needed for confirmation of the diagnosis and subsequent randomization. Subjects will be treated as inpatients for at least 1 week after Randomization. After this period subjects may be treated on an outpatient basis if the investigator is of the opinion that it is safe to do so.
    E.4Principal exclusion criteria
    a) have any other current psychiatric diagnosis (according to the MINI-Plus) except MDD, such as organic mental syndromes and disorders, delirium or anxiety disorders;
    b) have a lifetime psychiatric diagnosis of psychotic disorders (according to the MINI), or a MINI diagnosis of past manic episode. Subjects with a MINI diagnosis of past hypomanic episode can be enrolled, provided that their current episode is not hypomanic. Subjects with a MINI diagnosis of panic disorder lifetime can be enrolled, provided that they do not have the MINI diagnosis of panic disorder current;
    c) are at significant risk of committing suicide, as indicated by a score greater than 9 on the revised ISST;
    d) are currently treated with carbamazepine or valproate;
    e) are currently treated with midazolam;
    f) have been treated with electroconvulsive therapy (ECT) in the current episode;
    g) are currently treated with more than one antidepressant;
    h) are currently treated with more than one antipsychotic;
    i) are currently treated with more than one mood stabilizer;
    j) have “usual treatment” started or discontinued in the 2 weeks before Randomization.
    k) have a “usual treatment” dose change within the week prior to Randomization;
    l) have any clinically unstable or uncontrollable renal, hepatic, respiratory, hematological, cardiovascular or cerebrovascular disease that would put the patient at risk of safety or bias assessment of efficacy;
    m) have known hypersensitivity reactions to glucocorticoid antagonists;
    n) have any clinically significant abnormal laboratory data (e.g. aspartate amino transferase (ASAT) and/or alanine amino transferase (ALAT) values > 2x normal range upper limit) or ECG results, or a clinically significant abnormal outcome at the physical examination at the screening visit;
    o) have any untreated or uncompensated clinically significant endocrine disorder;
    p) have a MINI-Plus diagnosis of alcohol and/or drug dependence;
    q) have a confirmed positive result on the drug screening test for any illicit drug, except cannabis, at Screening;
    r) are using hormone replacement therapy at Screening;
    s) require concomitant treatment with corticosteroids, like dexamethasone, prednisone or cortisol (topical use is allowed);
    t) are subjects diagnosed with Cushing’s disease;
    u) are women of childbearing potential without adequate contraception (an IUD or oral contraceptives in combination with a barrier method are considered adequate; in addition, a condom, used in combination with a spermicide paste, or prepared with such a paste, is also considered adequate);
    v) are women with a positive pregnancy test at Screening or Baseline, or are breastfeeding mothers;
    w) Are male subjects with a current diagnosis of prostate hypertrophia or past history (less than 3 months) of symptoms of prostate hypertrophia. Subjects, whose symptoms of prostate hypertrophia were not more recent than 3 months, may be included based on a negative Prostate-Specific Antigen (PSA) test (PSA blood level lower than 4.0 ng/mL) and medical judgment;
    x) Are currently treated with clozapine;
    y) Are currently treated with systemic ketoconazole. Topical use is also prohibited.
    E.5 End points
    E.5.1Primary end point(s)
    The PANSS positive symptoms score proportion of 50% responders at both Day 8 and Day 43.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2004-07-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 300
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2004-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-07-17
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